Clinical Trial: Dehydrated Human Amnion/Chorion Membrane Micrografts(dHACM) Injectable in the Treatment of Recalcitrant Plantar Fasciitis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Prospective, Randomized, Controlled, Blinded, Comparative Study of Dehydrated Human Amnion/Chorion Membrane Micrografts(dHACM) Injectable in the Treatment of Recalcitrant Plant

Brief Summary: This is a prospective, controlled, randomized, blinded and comparative, single-center clinical trial comparing the improvement of patients with recalcitrant plantar fasciitis symptoms that have received standard of care versus treatment with differing amounts of injectable dehydrated human amnion/chorion membrane micrografts(dHACM).

Detailed Summary:
Sponsor: MiMedx Group, Inc.

Current Primary Outcome: Reduction of inflammation as measured by AOFAS Hindfoot scores [ Time Frame: 8 Weeks ]

The primary objective of this study is to compare the efficacy of the different treatment amounts in reduction of inflammation as measured by AOFAS Hindfoot scores.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Return to normal activities more quickly than with standard of care [ Time Frame: 8 Weeks ]
    The secondary objective is to demonstrate that patients treated with micronized dHACM injectable will return to normal activities more quickly than with standard of care.
  • Pain as measured by 0-10 Numeric Rating Scale [ Time Frame: 12 weeks ]
    Patient pain scores will be assessed between all groups.


Original Secondary Outcome: Same as current

Information By: MiMedx Group, Inc.

Dates:
Date Received: October 10, 2013
Date Started: September 2013
Date Completion:
Last Updated: June 12, 2014
Last Verified: June 2014